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OpenTrials
Completed

NCT Number: NCT02126228

no Antibiotics for Elective Cesarean With Low Risk of Infection

The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.

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Key information

Conditions

Antibiotics , Elective Cesarean, China

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

2nd Hospital of Shandong University

Jinan, Shandong, 250033, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cesarean
  • With normal temperature;
  • No signs of infection;
  • Normal degree of cleanliness in vaginal; .Normal amniotic fluid.

Exclusion criteria

  • Failure of vaginal delivery and emergency cesarean;
  • Premature rupture of membranes;
  • Antibiotics having been applied to 3 days before cesarean;
  • Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis;
  • Having infections in respiratory or urinary system before cesarean;
  • Placenta previa or placental abruption;
  • With medical and surgical complications;
  • BMI ≥ 30kg/m2;
  • Total blood loss more than 1000ml within 2 hours after cesarean

Treatment and study plan

Primary outcomes

  1. Temperature

    Time frame: 3days

Secondary outcomes

  1. Postpartum hemorrhage volume estimates and Routine blood test.

    Time frame: 3days

Other outcomes

  1. Observation of puerperal infection

    Time frame: 30days

    Incision healing;Intrauterine infection;Pelvic and abdominal infection;Infection of urinary system

Sponsors and collaborators

Lead sponsor

Fanzhen Hong

Other

Registry information

Official study title

A Randomized Controlled Trial on Antibiotics Application For Low Infection-risked Elective Cesarean

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2014
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.